Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
miraDry System consisting of the MD4000-MC Console Recalled by Miramar Labs, Inc. Due to Update to labeling for the miraDry Console to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Miramar Labs, Inc. directly.
Affected Products
miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.
Quantity: 277 units
Why Was This Recalled?
Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Miramar Labs, Inc.
Miramar Labs, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report